On August 5th we introduced the notion that there is an overwhelming abundance of information available at the fingertips of the consumer. In Part One we took a closer look at the role of the FDA in Personalized Genomics and direct-to-consumer genetic tests. Now in Part Two we will take a closer look at the role of the FDA in regulating mobile medical applications.
Anyone with a smartphone can describe the dizzying array of apps relating to your health. A cursory review of the health and fitness category of the Apple App Store reveals apps to count calories, track diet, monitor heart rate, steps taken, and distance ran; the list goes on and on.
On September 25, 2013 the FDA issued a guidance on Mobile Medical Applications. This guidance dealt with the subset of mobile apps that meet the definition of a medical device and whose functionality could affect patient safety if the app were not to work properly. The distinction is important since the FDA has the ability to utilize discretion on an app that may meet the definition of a medical device but may pose a lower risk to the public. As such, the FDA provided examples of apps that may or may not fall under the need for regulatory oversight. Mobile medical apps that fall under umbrella of regulatory oversight include apps that can transform “a mobile platform into a regulated medical device by using attachments, display screens, sensors, or other such methods.” For example, an app that controls inflation of a blood pressure cuff or delivery of insulin would require FDA oversight.
Alternatively there are a number of categories where the FDA may exercise oversight and enforcement. This includes apps designed to:
- Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions
- Provide patients with simple tools to organize and track their health information
- Provide easy access to information related to patients’ health conditions or treatments
- Help patients document, show, or communicate potential medical conditions to health care providers
- Automate simple tasks for health care providers
- Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (HER) systems
Additional appendices in the guidance provide examples of specific apps and which category they fall into [Appendix A - Not medical device; Appendix B - Medical device with enforcement discretion; Appendix C - Medical device with oversight]. As one would imagine, with the number of apps being developed on a daily basis there is a continual barrage of apps that need to be evaluated and the lines may become blurred rather quickly. Additionally, Apple, the company providing the platform for a large number of these mobile medical apps, has met with the FDA on a number of occasions. One such occasion in December of 2013 dealt with which medical device apps, hardware, or software would trigger FDA regulation. As reported by Apple Toolbox in June 2014 and FDA after a Freedom of Information Act request, the meeting in December touched on a number of topics related to the September guidance. At this meeting, a theme of communication and openness between the two parties was discussed. A general takeaway from this meeting can be that providing information may not trigger regulation but providing an interpretation of such information might. Similar to direct-to-consumer genomic testing [link to previous blog], having a particular sensor or providing certain health information may not trigger the need for Federal Regulation; the distinction is in the intended use of the app. An example provided in the meeting dealt with blood sugar. An app that provides blood-sugar information in order to aid in nutrition may not require oversight, but if that same app is marketed for diabetics then it would require oversight.
This meeting also underscores the dynamic motion between developers/companies and the FDA. Since the guidance was issued in September 2013 the FDA has provided additional examples of apps that fall under Appendix B (Medical device with FDA enforcement discretion). As reported in Mobihealthnews, the FDA has added four descriptions of medical device apps that would not fall under the need for FDA regulation in 2014.
- Mobile apps for providers that help track or manage patient immunizations by assessing the need for immunization, consent form, and immunization lot number [March 12, 2014]
- Mobile apps that provide drug-drug interactions and relevant safety information (side effects, drug interactions, active ingredient) as a report based on demographic data (age, gender), clinical information (current diagnosis), and current medications [March 12, 2014]
- Mobile apps that enable, during an encounter, a health care provider to access their patient’s personal health record (health information) that is either hosted on a web-based or other platform [March 12, 2014]
- Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight, or other data from a device to eventually share with a health care provider, or upload it to an online (cloud) database, personal or electronic health record [June 11, 2014]
The most recent addition is very similar to a new feature of Apple iOS 8, the HealthKit App which will be released in September 2014 and was first introduced in June 2014. This app, embedded in the new operating system, will provide a dashboard to monitor health and fitness data. As an alternative to the HealthKit App, Google also announced in June of 2014 the Google Fit App. While similar to the HealthKit App, the Google fit app provides a platform for managing health information being gathered from third party apps.
We, the consumer, are merely scratching the surface on what information our phones, watches, computers, tablets, etc. can provide to us. It will be interesting to watch the interplay between developers and companies with the FDA as the pace of development further increases. The distinction between information and interpretation or intended users will require close and continual examination. As a reader and consumer, are you overwhelmed or excited about the options that are available today and what will be coming in the future? Stay tuned as we will occasionally discuss in the future in greater detail specific genomic tests or mobile health apps.
Photo Credit: mag3737