Pharma Mobile Health App Best Practices Survey 
There are tens of thousands of medical, health and fitness apps on the market and their sheer number makes it difficult for health care professionals and consumers to locate apps that operate reliably, are based on valid information, and safeguard users’ information.”
The Pharma Mobile Health App Best Practices Survey asks your opinion regarding several issues faced by pharma companies when developing mobile applications (apps) for physicians and consumers. Issues include impact of regulation by FDA, privacy, trust, accuracy, and 3rd-party certification as well as industry self-regulatory guidelines.
“Sooner or later,” said Pharmaguy, “Congress is going to be investigating mobile health apps to see if further regulations — not just FDA regulations — are required. IMHO, the pharmaceutical industry (i.e., PhRMA) should differentiate itself from the “wild west” developers by being pro-active in issuing Guidelines for Mobile Health Apps Developed by the Pharmaceutical Industry in much the same manner as it developed other self-regulatory guidelines such as PhRMA’s DTC Guiding Principles and the Code on Interactions With Healthcare Professionals. However, this time, PhRMA should act BEFORE Congress or the FDA takes the first step!”
What Do You Think?
The Pharma Mobile Health App Best Practices Survey asks whether or not you agree that it is in the drug industry’s best interest to police itself and develop best practices or self-regulatory guidelines for developing trustworthy health/medical apps for consumers and physicians.
It also asks if you agree or disagree with the following statements:
- Apps must include full disclosure regarding the company that has created the app or the sponsoring pharma company. This includes contact information. BRANDED apps MUST include ISI (important safety information) up front in an easily accessible manner (e.g., on start-up screen).
- Apps that are BRANDED (i.e., mention drug brand names) must be available ONLY from the appropriate U.S. app site (e.g., Apple App Store) even if all the FDA-required ISI (important safety information) is included.
- Apps intended to be used by healthcare professionals in the U.S. must be HIPAA compliant.
- If an app collects personal information, it should include a privacy policy that explains how such data is protected (security), who owns the data, how users can access the data, where data is stored (on device or on remote web site) and instructions for opting out of data collection.
- The pharmaceutical industry has to police itself with regard to development of all health apps regardless of what regulations FDA may impose.
- The app should include appropriate disclaimers and terms of use that the user MUST agree to before the app will run.
- All health/medical apps should be certified by third parties such as Happtique.
- If an app relies on algorithms or formulas, it must be validated through rigorous testing and documentation to ensure it works properly (i.e,. calculations are correct).
Please take a few minutes to respond to this survey here. The summary of results will be published in a future issue of Pharma Marketing News. You may remain anonymous or you may provide your name and contact information if you wish to be quoted in the published summary.
