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FDA Mobile App Guidelines For The Common Joe

FDA Mobile App Guidelines For The Common Joe

It’s quite a task for an average Joe to understand the complex reporting and regulatory guidelines set up by government officials. Businesses built on ignorance and lack of guidance on the government’s law can be fatal. Having a strong understanding of the fundamentals of city, county, state and country laws can help your business thrive… and fend off potential lawsuits.

Talking with our healthcare mobile app customers, one of the most difficult entities and regulation system to understand is the Food and Drug Administration (FDA). Knowing this, we’ve created mobile app guidelines of the FDA for the common Joe. The aim is to help those not versed in legalese understand FDA’s regulations on healthcare mobile apps.

FDA Mobile App Guidelines For The Common Joe

What Is The FDA?

The Food and Drug Administration (FDA) is a US government agency. It works for the welfare of public health by taking complete authority in regulating food and drugs – No surprise there. The FDA has regulatory authority in: Veterinary medicines, vaccines, dietary supplements, cosmetics, medical devices, tobacco products, and in advancing medical innovations for the benefit of the people. Due to the ever growing popularity of mobile apps for day to day healthcare, the FDA created an entire digital division.

The Role Of FDA In Mobile Apps

FDA created a general policies and guidelines to measure if a mobile app is for the benefit of the people and causes them no harm. For a healthcare mobile app company, it’s really important to strictly adhere to FDA’s guidelines. However, FDA clearly states that it will regulate only those mobile apps that behave like a medical device and pose a major threat to human life.

FDA’s Regulatory Approach

According to the FDA, any mobile app which intends to cure, diagnose or prevent a disease is a medical device. Such mobile apps must clear FDA’s approval before they’re released on the app store, ensuring the safety of the people. Based on this, FDA’s regulatory approach on mobile apps can be categorized into two main sections. Before we cover that, it’s vital to understand the FDA’s definition of a, “medical” mobile app.

Mobile Apps That Are NOT Medical Apps

FDA isn’t responsible for the millions of mobile apps on the market. Mobile apps that are not intended to diagnose, cure, prevent or perform any clinical assessment are not medical mobile apps. Here are the parameters to know if you’re app is NOT considered a medical device by the FDA.

Mobile apps which:

  1. Study materials or references, dictionaries, encyclopedias and translate medical terms in multiple languages
  2. Are intended for healthcare providers to be used as tools in medical education and training. This could be medical question/answer quiz apps, surgical and anatomy training videos and pictures.
  3. Help find medical facilities closest to user’s area with their GPS, give a complete comparison on the drugs and medical products within the user’s area, allow users to communicate to their physician and provide information on restaurants offering quality food in hygienic conditions and provide list of emergency medical hotline contacts.
  4. Send automated information on general healthcare operations, enable insurance claims and processing details, help users track, review, claim or pay medical bills online, plan and schedule hospital beds, generate reminders for medical appointments and help patients send their feedback and conduct surveys on their treatment procedure.

If your app solely does any of the above, then it’s not considered a medical mobile app.

The Two Sections:

#1 Mobile Medical Apps That Fall Under FDA’s Regulation

  1. Some mobile medical apps are controlled by the medical devices attached. Owing to the possible risks from those medical devices, these apps fall in FDA’s regulation.
    For example: Mobile apps that control the inflation or deflation of a blood-pressure cuff. In this case, blood pressure cuff (medical device) is controlled by the mobile app.
  2. Mobile apps that transform into a medical device by attaching sensors (internal or external), screen displays or by including any functionality similar to a medical device.
    For example: Mobile apps that use sensors for creating electronic stethoscope function are considered to transform the mobile platform into an electronic stethoscope.
  3. Mobile medical apps that perform patient-specific diagnosis, treatment or provide any recommendations or interpret data from a medical device. FDA regulations are applied to such medical apps as well.
    For example: Mobile apps that connect cardiac monitors and transfer, displaying data for patient-monitoring.

#2 Mobile Medical Apps That Fall Under FDA’s Enforcement Discretion

FDA has formulated, “enforcement discretion” on medical mobile apps which pose less risk. This means FDA will not regulate these apps.

Mobile apps which,

  1. Coach users, track, organize, and those intended to improve their health on daily basis.
  2. Provide simple tips, automate tasks and awareness of health to users and healthcare providers.
  3. Help users maintain their records and communicate their medical status to potential health care providers.
  4. Transfer, store or display the data in par with the medical devices.
  5. Provide oral health reminders, update and alert the hospitalization rates.
  6. Allow users to collect, maintain and share their blood pressure data for personal record.
  7. Guide users especially diabetes patients in developing healthier eating habits, calculate calories and increase their physical activities.
  8. Enable care takers of patients to send out emergency notifications in critical conditions.
  9. Help asthmatics track their inhaler usage or the location and environment which triggered asthma at that moment. Also, those apps which use GPS location to alert asthmatics on that particular environmental conditions.
  10. Record the patient-clinician conversations for future reference.
  11. Track medications and act like reminders for helping users to adhere to their medications without fail.
  12. Provides motivational guidance and help those who are trying to quit smoking, recovering from addictions, struggling from depression and anxiety.

FDA works for the common good and welfare of the people, including healthcare mobile app providers. By setting up these guidelines for healthcare mobile app providers, FDA helps ensure that safe and useful healthcare mobile apps reach the market. Also, emphasizing the importance and necessity of getting it approved by FDA for the safety of the people makes your app that much more credible.

And there you have it – A very brief healthcare mobile app guidelines for the common Joe. If you’re thinking about creating a healthcare mobile app, make sure to check out our latest webinar all about app budgeting (coming soon). Or, watch our Mobility In Healthcare webinar!

Interested in a medical mobile app? Contact our LA mobile app developers today!