Should Mobile Medical Apps Have Package Inserts?

The US Food and Drug Administration requires that drugs and devices have package inserts and the regulations concerning inserts changes or are modified on a periodic basis. The purpose of the package insert (also known as prescription drug product insert or professional labeling) is to provide detailed drug information compiled and distributed by the drug manufacturer, after FDA review and approval. 

There is presently no such requirement for mobile medical apps, despite the fact that more and more doctors are prescribing them. What should patients know when their doctor prescribes an app?  If we adopt the same format for drugs and devices, it would include:

1. Risks or warning information

2. An exact description of the app, its intended use and the year it was released

3. A black box warning if applicable

4. Recent major changes in how the app should be used

5. Contraindications for use

6. Warnings and precautions about adverse app events

7. Adverse reactions with other interventions, for example, if you are taking certain medicines or have had a certain device implanted, does that contraindicate use of the app.

8. Use in specific populations

9. Full prescribing information that is a table of contents for users

10. Off label warnings

Like drugs and devices, mobile medical apps should be clinically documented to be safe and effective. In the future, we should extend that to demonstrating that they are also cost-effective and link reimbursment to demonstrated value. Maybe sometime soon, when you download that app your doctor prescribed, you will see all this information and hopefully it will improve your outcome.

I'm sorry, but you probably won't get all the cotton downloaded but we all have to pay the price of progress.

Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs at