This morning I had a quick note from a reader about yesterday’s briefing, Apps Aren’t For Techies Anymore, with questions about both the proliferation of apps in the health care space and the lack of standardization of their content – and about the current status of the regulation of health care apps.
First, on the proliferation of apps – It is estimated that in 2015, of the 1.4 billion worldwide smartphone users, about 500 million will use some type of mobile health care application (see Global Mobile Health Trends and Figures Market Report 2013-2017). According to an IMS Institute for Healthcare Informatics Report, in December 2013, there were about 43,700 health-related apps available in Apple’s iTunes app store (No longer a novelty, medical apps are increasingly valuable to clinicians and patients).
Second, there are concerns about the content of apps – both about their effectiveness as health care aids and about the privacy and security of consumer health data. Of the 43,700 health-related apps discussed in the IMS Institute for Healthcare Informatics Report, researchers found that a little over half were legitimate health care applications. We covered the validity and reliability of mental health apps in our pieces, More Than 3,000 Mental Health Apps Available For Download, Limited Number With Evidence Of Efficacy and So Many Apps! Which Are Effective?. And, we covered the concerns about the sale of consumer data from fitness apps, FTC Analysis Of 12 Consumer Fitness Apps & Devices Found Consumer Health Information Shared With 76 Different Third Parties. Essentially, the current state of the health care app market is analogous to the “wild west” – Beware of the source of the app information, and don’t put anything into apps that you don’t want shared with the world.
When it comes to regulations, we’ve come a a long way in a few short years. In July 2011, the U.S. Food and Drug Administration (FDA) outlined its approach to oversight of health care smartphone applications. Proposing two types of apps:
- Apps that “are used as an accessory to medical device already regulated by the FDA,” such as those that allow a health care professional to look at an image and then make a diagnosis. (For example, FDA Approves First Mobile Diagnostic Radiology App)
- Apps that “transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices,” such as an app that turns a smartphone into an ultrasound. (For example, Researchers Debut Smartphone-Based Brain Activity Scanner)
In July 2012, the U.S. Congress passed The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which called for a health IT strategy (see The Food and Drug Administration Safety and Innovation Act of 2012). Then, in September 2013 the FDA issued its final guidelines that regulate mobile apps based on potential consumer harm (see Mobile Medical Applications – Guidance for Industry and Food and Drug Administration Staff).
While these guidelines have been repeatedly described as “gray” and inexact, any organization that seeks to utilize or develop their own app should keep a few “talking points” in mind during their next executive discussion. Writing for iMedicalApps (see The Clinicians’ Guide To FDA Regulations On Mobile Medical Apps), Satish Misra, MD groups apps into five possible regulatory categories:
- The FDA plans to regulate apps that are an extension of a medical device; transform a mobile platform into a regulated medical device; perform patient-specific analysis, providing diagnosis/treatment recommendations.
- General reference and education apps, as well as apps for administrative functions (such a billing), are not medical devices.
- Apps that may be medical devices but are deemed “low risk” (such as apps that regulate chronic diseases through behavioral interventions and wellness promotion) won’t be regulated.
- Apps that automate functions and can be “safely used by a patient without oversight…[and] is not intended to replace or discourage seeking treatment.” such as provide general knowledge or provide EHR access, will also not be regulated.
- Apps that use peripheral sensors (e.g., analyze a test strip) or connect to and manage regulated devices will be deemed both a medical device, and pose a high enough risk to warrant regulation.
If this sounds inexact, that’s because it is – but this is a technology that consumers are already adopting, and the well-prepared organization will develop a strategy to take advantage of that. For more, join Jonathan Evans, President & Chief Executive Officer, Safe Harbor Behavioral Health; Deb L. Heggie, Ph.D., Corporate Chief Clinical Officer, Magellan Healthcare; Peter Antall, M.D., President & Chief Medical Officer, Online Care Group; and OPEN MINDS Senior Associate George Braunstein for their session, How To Create Tech-Enabled Consumers: Using Technology To Increase Consumer Engagement & Build Relationships, at The 2014 OPEN MINDS Technology & Informatics Institute.