Mobile health application developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration published its long-awaited final guidance on mobile medical applications under the Federal Food, Drug, and Cosmetic Act. It is vital for any app developer to understand whether the guidance applies to their product from the initial design stage. Those who are already marketing software and apps that involve healthcare should also review the guidance with care to try to determine how FDA’s new regime impacts both business plans and continuing operations.
The relationship between privacy and mobile applications is coming into focus. On February 27, 2012, the California Attorney General entered into a Joint Statement of Principles with the six largest mobile application companies – Apple, Google, H-P, Microsoft, Amazon and RIM – regarding consumer privacy and transparency issues when data is collected through an app. http://ag.ca.gov/cms_attachments/press/pdfs/n2647_agreement.pdf. The Five Principles set parameters for good practice. Although not legally binding, the AG promises to review compliance in the fall, and may use California laws on privacy, false advertising, unfair business practices and others as enforcement tools. Since California often leads the way in privacy enforcement it is likely that other states will follow suit.