News Feature | February 19, 2015

FDA To Relax mHealth Regulations

Katie Wike

By Katie Wike, contributing writer


In a recently released final guidance document, the FDA details its plans to loosen regulations on mobile apps and medical device data systems.

In two final guidance documents, the FDA has announced it will be easing regulations on mobile apps and medical device data systems (MDDS). According to Health Data Management, MDDS is hardware or software that is used to convert and display data from medical devices such as glucose meters and blood pressure cuffs.

“The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health,” notes one of the final guidance documents.

In the other final guidance issued, the FDA explained it will regulate mobile apps based on their functionality rather than their sale. According to iHealth Beat, this means apps that perform medical device functions will be regulated, while apps that are not considered to have a medical function will not be regulated by the agency. This includes apps designed to:

  • automate simple tasks for providers
  • interact with providers via electronic health record systems
  • self-manage conditions, without offering specific treatment suggestions
  • organize or track health information

The FDA explains it “recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes.”

Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, said about the changes, “The implications are profound, both for MDDS type software, but also for what it suggests about the future for health information technology generally. FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software.”