Posted by:Monica Samuel May 15th, 2013

mHealth  apps and medical devices have become hugely popular. The number of people who downloaded health related mobile apps in 2012 touched 247 million, a 200% jump from 2011. That’s great news for healthcare software solution vendors. However, with the change in the regulatory landscape, app developers must also understand FDA Draft Guidance governing the design, development and performance of specific categories of medical mobile applications.

FDA regulations – Scope

FDA will not regulate all healthcare mobile apps. Health and wellness apps that aim to help individuals improve their health but do not include capabilities meant to diagnose, cure, mitigate, treat, or prevent diseases will not be regulated. Other mobile solutions like e-books, mLearning solutions, office tools, and personal health record systems are out of the loop too.

So, who’s in? FDA will regulate mobile apps the same as medical devices if they store, transmit, display, control or analyze medical patient data. These include mobile medical imaging solutions (teleradiology, telecardiology, medical simulators, etc.), mobile solutions that analyze, assess or interpret electrocardiograms or electroencephalograms; solutions that control medical devices that monitor vital statistics with or without attachments (blood pressure, heartbeat, sleep patterns, etc.); and apps that offer functionalities similar to medical devices. Mobile applications that suggest treatments based on a users’ inputs fall under FDA purview too.

Why FDA regulation?

There are over 40,000 medical applications available on app stores. The increasing popularity of healthcare wellness and self-care applications, though a good sign, creates genuine concerns. While mobile health apps help users take better care of their health, a small inaccuracy in design or code (formula) could misguide users into taking steps that impact their health negatively.

How does it work?

fda_regulates_mobile_apps

Any mobile application that – through its advertizing, marketing, labeling, promotion or functioning – claims to work as a medical device will be subject to FDA 501(k) Approval Process or the FDA Premarket Approval Process (PMA) before it can be marketed. The controls will vary with the classification of the medical mobile app (low, medium or high risk in case of failure.)

Mobile application developers – Need to know

FDA regulations must be kept in mind through the lifecycle of a mHealth application. App developers will need to:

  • define, document, implement, and maintain procedures for validating medical device design
  • meet a ‘level of confidence’ (based on the validation exercise) that will differ for each app
  • observe principles of documentation and defect prevention through the product lifecycle
  • design apps for usability, factoring in human error
  • specify (in design) – risk analysis; hardware; built-in error, alarms, warnings; communication links; and security measures
  • enable traceability analysis
  • implement ‘mini life cycle’ and validation process after any change in software
  • document corrections and notify FDA within 10 days if correction reduces risk to health posed by the app or remedies an FDCA violation
  • submit a PMA supplement including PMA amendments for FDA review in case of changes in the mobile app’s performance or design specifications, circuits, components, principles of operation, or physical layout (if they impact safety or performance)
  • conform to other regulatory bodies (if required) such as FTC, ONC, FCC, and OCR
The FDA guidelines do not cover gray areas such as a network fluctuation that causes a medical app to fail. Hopefully, the final guideline that’s expected to release in 2013 will clear ambiguity. Till then, mobile app developers should keep FDA guidelines in mind for quick FDA approval.

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