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FDA Approval for Mobile Apps

There are a myriad of mobile medical applications (apps) now available to download for anyone who owns a smart phone, tablet, or PDA. According to the Associated Press, there are over 17,000 mobile medical apps currently available. The functionality of these apps ranges from calculating one’s BMI to directly viewing a patient’s electronic medical records to allowing a physician to review a patient’s x-ray films on his/her iPad and making a diagnosis based on that image.  Mobile medical apps are clearly tools that can significantly determine and alter patient care.

As of June 2012, the US Food & Drug Administration (FDA) had not released an official policy for regulating the production and release of mobile medical apps. On July 21, 2011, the FDA outlined the types of mobile medical apps for which they intended to enforce strict regulations to ensure patient safety. The Draft Guidance was open for public comment from manufacturers, health care providers, and others for 3 months. The period for comments and feedback concluded in October 2011, and now the FDA is reviewing the comments and deciding on what revisions to make. The Draft Guidance can be reviewed here.

The Draft Guidance specifically defines a small subset of mobile medical apps that the FDA intends to regulate applications that:

  • Are used as an accessory to a medical device already regulated by the FDA (eg, Mobile MIM, AirStrip OB)
  • Transform a mobile platform into a regulated medical device by using attachments, sensors, or other devices (eg, any app that transforms a mobile device into an electrocardiogram (ECG) machine using attachments, or an app that can be used as a blood glucose analyzer with an attachment)
  • Allow the user to input patient-specific data and, using algorithms and formulas, output patient-specific results regarding diagnosis, treatment, prognosis (eg, an app that collects patient information and can calculate index scores or calculate dosages for a medication)

Two mobile medical apps that have already been approved by the FDA for use by physicians and which fall under the two guidelines above are Mobile MIM and AirStrip OB.

  • Mobile MIM is an app that allows physicians to view images from their mobile device and to make diagnoses based on these images, including computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, and positron-emission tomography (PET) scans.
  • AirStrip OB is a mobile app that allows obstetricians to remotely access real-time fetal heart tracings and maternal contraction patterns with annotations.

These apps warrant regulation because physicians base their patient management decisions on the information relayed by these apps, similar to how physicians base their medical decisions on the readings of an ECG machine. And just as ECG machines are regulated by the FDA, these apps need to be regulated to ensure patient safety.

Apps that the FDA will not be regulating include those that:

  • Are electronic copies of reference materials and medical textbooks, teaching aids, or training guides (eg, flash cards, quizzes, lists, review materials)
  • Are used to track, record, evaluate, log, or make decisions regarding general health and well-being (eg, dietary tracking logs, appointment reminders, dietary recommendations based on a calorie counter, exercise suggestions, any similar app that promotes health and wellness)
  • Automate office operations, including billing, inventory, appointments, or insurance transactions (eg, apps that determine ICD-9 codes, enable insurance claims data collection, and other administrative tasks)
  • Are generic aids not marketed for medical use (eg, magnifying glass app, recording audio, note taking)

For those apps that do fall within the regulatory oversight of the FDA, manufacturers must meet the requirements associated with the appropriate classification of risk: Class I (low-risk), Class II (moderate risk), and Class III (high risk). More information on each specific classification and appropriate measures can be found on the FDA website.

Two main concerns arise from patients and physicians regarding the FDA approval of mobile medical apps:

  • Privacy. The concern is that confidential patient information becomes too easily accessible once physicians start accessing images and patient data on their mobile platforms. If a physician’s phone were stolen or misplaced, confidential patient information would be at risk.
  • Pricing and fees. The other concern surrounds the economics of mobile apps. Potentially very useful apps could become unnecessarily expensive to the end user due to the costs manufacturers incur for obtaining FDA approval. In addition, smaller app developers that cannot afford these FDA fees would be at a disadvantage, possibly restricting the mobile medical app market to a handful of manufacturers.

On the flip side, FDA regulation has its benefits, conveying credibility and patient safety to effective and efficient mobile medical apps, thereby helping to further the technologic advances that are sure to come in the near future.

The FDA has not yet announced an expected release date for their mobile app guidelines, which will inevitably guide future mobile integration. Until the FDA has made their statement, interested providers can review a running list of peer-reviewed articles about apps for orthopaedic surgeons here and a list of validated apps here.

References

Nov 2011: Emergency Medicine News article FDA to Regulate Mobile Medical Apps

Oct 2011: InformationWeek Healthcare article Should Medical Mobile Apps Require FDA Approval

Sep 2011: Health Reform Watch article FDA Drafts Guidance on Mobile Medical Apps

Jul 2011: Associated Press article FDA Plans to Regulate Some Mobile Phone Apps

Jul 2011: FDA Draft Guidance Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications

Feb 2011: FDA News Release FDA clears first diagnostic radiology application for mobile devices

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