FDA Regulations on Medical Apps: What They DO and DON’T Regulate

Building a healthcare app that complies with Health Insurance Portability and Accountability (HIPAA) is synonymous with abiding by US Food and Drug Administration (FDA) regulations. While HIPAA mandates all medical and healthcare applications to have privacy and security protocols, the FDA requires all medical applications to meet quality standards by providing efficient services to users. 

HIPAA even covers healthcare apps, while the FDA only regulates medical apps. Though healthcare app developers and owners still need to make sure that they deliver high-quality, efficient experiences to users, they do not face strict regulations from FDA.

The FDA focuses its monitoring on medical apps which require careful screening from government authorities due to the sensitivity of the documents being transferred online. The FDA requires all medical apps to adhere to its regulations and submit evidence of compliance with data privacy and security standards. Medical app owners also need to submit verification documents to prove that their apps are able to provide efficient services to users. 

Because of the pandemic and accompanying rising medical concerns, healthcare app development has now become a public service and the government calls for accountability among stakeholders. 

Categories of Devices

To clarify what exactly the FDA requires, let’s start by reviewing the categories of devices:

A. Software applications that are not categorized as medical apps. These apps are not covered by FDA regulations.

B. Software applications that are not categorized as medical apps, and do not cause privacy and security threats. These apps are not covered by FDA regulations.

C. Software applications that are categorized as medical apps may cause privacy and security threats. These apps are covered by FDA regulations.

To distinguish which software applications DO NOT fall under the medical app category, here are some descriptions:

1. Academic medical resources such as e-books, e-journals, and e-periodicals
2. Academic and continuing professional education training resources for medical practitioners
3. Financial management applications
4. Call and video collaboration platforms
5. Illustrations for education and training for medical practitioners and patients
6. Retrieval platforms for non-sensitive information
7. Benchmarking tools for medical costs and supplies

There are also some medical apps that don’t pose a direct privacy or security threat to users. 

Here are the types of apps that the FDA need not impose stringent policies upon:

1. Education apps that teach strategies on coping with mental health
2. Apps that give advice and guidelines to people on how to stop smoking or start a daily exercise routine
3. Apps that help users monitor their asthma
4. Apps that notify users about their medicine schedules, intake, and the specific dosage for each pill
5. Apps that provide insights on illnesses and diseases 
6. Apps that house logs of users’ blood pressure checks

Now that we have sorted the apps that do not need to abide by the stringent FDA regulations, here is the list of the types of apps that DO need to.

1. Apps that use sensors to check heart rate and potential illnesses, and are integrated with ECG hardware
2. Apps that detect bodily changes that may or may not be submitted for additional testing
3. Apps that deal with ear surgeries and assistance
4. Apps that assist in volume control to help doctors hear a heartbeat better
5. Apps that assist in the treatment of the heart
6. Apps that transfer data from medical hardware to monitors
7. Apps that integrate with medical devices to assist in at-home labor and delivery

Non-FDA Regulated App Attributes

There are specific attributes of healthcare and medical applications that make them fall under either the FDA regulated or non-FDA regulated categories. One key identifier is the medical document disclosure. If the document contains sensitive information and it is official medical data, then it should be encrypted. FDA will track apps that do not encrypt confidential medical information.

The common qualities of apps that are non-FDA regulated are those that do not transfer official medical records or laboratory results digitally, do not share sensitive or confidential information about users, and those that are just storing basic health data like blood pressure, number of steps, or calories burned. 

Informative and educational health apps do not need to face stringent rules from FDA and are allowed to freely share insights with users. Also, some mental health apps that give advice and share motivational articles are allowed to engage with their users.

FDA Regulated App Attributes 

The FDA is likely to place stricter regulations on applications that have integration and data transfer activities with medical devices such as sensors. These sensors can aid in detecting heart illnesses, increase the volume of heartbeat sounds to closely monitor critical cases, and serve as the eye of the doctors to virtually observe and diagnose a remote patient. 

These medical apps have direct interaction with an actual medical device or equipment and the data being captured, transferred, and stored are being used for diagnosis or treatment of the patient. These apps require closer screening from the FDA.

Apps like these have a direct influence on the current medical condition of patients, and because of this, the FDA holds app developers and owners accountable for the results of their operations. The FDA regularly checks these medical apps because patients deserve to receive reliable, safe, and responsible health services. 

Even though an app is giving health care service that is non-medical in operation, it is wise to add layers of data privacy and security such as using blockchain technology. Blockchain helps in decentralizing the location source of files, making it difficult for hackers to attack and steal information.  

Also, it is best to start with an HTTPS protocol as the foundation of the live app. An HTTPS-driven platform is a good base for integrating encryption technology in your app. Two-way authentication and other forms of logging in such as facial recognition, thumbprint, and voice can be added to prevent identity theft. 

Investing in a dedicated private cloud server helps ensure that the app data is kept protected from viruses and malware. Furthermore, integrating artificial intelligence in healthcare apps enables devices to perform more complex tasks. 

It is projected that soon these technologies will be required for all apps to protect users from identity theft and cyber-attacks. It is wise to start building your app using these advanced technologies now, so you do not need to revamp the entire app when the government mandates these regulations down the road. 

If you are planning to build a medical app for your hospital, clinic, or private practice; contact Digital Authority Partners to help you with the process as well as with complying with HIPAA and FDA regulations.