Mobile health apps have the potential to make doctors more efficient and reduce the cost of health care.  In addition, these apps can increase patient satisfaction and understanding, while empowering them to take charge of their own health.  One of these includes Medscape.  Medscape is free and is also the fastest growing medical app with a 4 ½ star rating.  1 in 2 U.S. physicians and 3 out of 4 medical students use Medscape.  Medscape’s most popular feature is the disease and drug information news feed.  It also includes medical calculators, drug formulary information, and medical educational courses.

While not all healthcare applications fall under HIPAA rules, those that collect, store, or share personally identifiable health information with covered entities (such as doctors and hospitals) must be HIPAA-compliant.  Here are a few things to remember if making a medical app.  If your application is going to send or share health data to a doctor, hospital, or other covered entity, it must be HIPAA-compliant.  Getting certified as HIPAA-compliant as a developer can help ensure you have the systems and processes in place to properly safeguard protected health information (PH) and meet compliance standards outlined by the law.  The next step is making sure that it allows its users (HIPAA covered entities or business associates) to fully comply with the HIPAA Privacy, Security, and Breach Notification Rules.  You will need to focus on how your application shares PHI, what security measures are in place, and how a user can tell if the information has been breached.  Some steps to becoming certified include:

  1. Determine a reputable provider
  2. Determine an HIPAA Certification level
  3. Complete the class
  4. Ace the test
  5. Keep up to date on the materials.

When creating a mobile health app, you also need to consider whether your app needs FDA approval.  The FDA’s role in mHealth isn’t completely clear, but certainly they will provide some oversight.  The FDA put out draft guidelines for mobile medical apps for comment in July of 2011.  The draft guidance details how the FDA plans to apply regulatory authority to mHealth apps.  The FDA should be publishing the final guidelines any time now.  In the draft guidance, the FDA defines a mobile medical app as an app that is used as an accessory to a regulated medical device, or transforms a medical device into a regulated medical device.  From this, we think that the FDA is likely to allow wellness apps to continue unregulated.  It also appears that the FDA is taking a much closer look at apps that could be considered a medical device.  For example, on May 21st, 2013, The FDA sent an official warning letter to Biosense Technologies Private Limited in regards to their uChek Urine Analyzer.

Article contributed by Bryce Stevenson