Which Healthcare Laws Apply to Your Healthcare App in the USA?

6 min read

This is the most simplified blog ever written on healthcare laws! 

If you are having a hard time understanding the healthcare laws and which laws apply to your healthcare app or tool, you’ve landed on the right page. 

Let’s come straight to the point. 

US Healthcare Regulations and Compliance

1) Who regulates the healthcare industry?

The US is one of the largest and flourishing healthcare industries. But jumping into the US healthcare industry is not as easy as it sounds. Multiple healthcare laws and federal approval make it one of the toughest tasks to launch any healthcare product in the US market. 

Healthcare laws in the USA apply to Health Information Technology (HIT), mobile health, personalized prescriptions, wearable technology and telehealth.  

When it comes to regulating the US healthcare industry, three government bodies play a major role. These government bodies are, 

  • Food and Drug Administration (FDA)
  • Federal Trade Commission (FTC)
  • Office of Civil Rights (OCR) 

2) What are the top healthcare laws in the USA? 

You should adhere to relevant healthcare law(s) if your healthcare mobile app collects, creates and shares consumer information. 

The following are the top 4 healthcare laws applicable in the USA. 

  • Health Insurance Portability and Accountability Act (HIPAA)
  • Federal Food, Drug, and Cosmetic Act (FD&C Act)
  • Federal Trade Commission Act (FTC Act)
  • FTC’s Health Breach Notification Rule

3) Which laws apply to your healthcare mobile app? 

The following are 10 questions that help you identify which healthcare laws apply to your healthcare mobile app. 

Question 1: Do you create, receive, save personal information of patients? 

If Yes Go to Question 2 to know if HIPAA applies. 

If No HIPAA does not apply. (But the FD&C Act might apply. Go to Question 5 to verify.)

Question 2: Are you a healthcare provider?

If Yes HIPAA applies. (Go to Question 5 to see if the FD&C Act also applies.) 

If No HIPAA might apply. (Go to Question 3 to validate.)

Question 3: Is it mandatory for users to have a prescription to access your app? 

If Yes HIPAA applies. ( The FD&C Act might apply as well. Go to Question 5 to verify.)

If No HIPAA might apply. (Go to Question 4 to validate.)

Question 4: Are you developing this app on behalf of the hospital, doctor’s office, health insurer?

If Yes You are called HIPAA Business Associate. Thus, you are subject to HIPAA Security Rule and HIPAA Privacy and Breach Notification Rules. (The FD&C Act might apply as well. Go to Question 5 to verify.)

If No HIPAA does not apply. (But the FD&C Act might apply. Go to Question 5 to verify.)

Question 5: Are the diagnosis of a disease, its treatment, and prevention of disease major uses of your app? 

If Yes Your app is the medical device. Thus, the FD&C Act applies. (Go to Question 6 to see if the FDA gives you an exception.)

If No The FD&C Act does not apply. (But the FTC Act might apply. Go to Question 8 to validate.)

Question 6: Does your app fall under the “minimal risk” category? 

If Yes  FD&C Act does not apply. (FDA gives you an exception.)

If No FD&C act applies. (Go to Question 7 to see if the FDA still gives you an exception.)

Your app is falling under the ‘minimal risk’ category,

  • If it is helping users to manage their healthcare condition by themselves without offering treatment suggestions. 
  • If it is offering very straightforward tools to users to keep an eye on their health information and track it.
  • If it is automating day-to-day tasks for healthcare providers. 
  • If it is facilitating users or healthcare providers to interact with the EHR system. 

Question 7: Is your app a “mobile medical app?”

If Yes FDA gives you an exception. (But the FTC Act might apply. Go to Question 8 to validate.)

If No Please contact the FDA at mobilemedicalapps@fda.hhs.gov to validate whether FDA Act applies or not. (FTC Act might apply as well. Go to Question 8 to validate.)

Your mobile app falls under “mobile medical app” category, 

  • If it acts as an accessory to a regulated medical device. 
  • If it transfers the mobile device into a regulated medical device such as a glucose meter. 
  • If it analyzes data from another medical device. 

Question 8: Are you a nonprofit organization?

If Yes The FTC Act does not apply. ( But FTC’s Health Breach Notification Rule might apply. Go to Question 9 to validate.)

If No The FTC Act Applies. (FTC’s Health Breach Notification Rule might apply as well. Go to Question 9 to validate.)

Question 9: Are you developing this app as or on behalf of a hospital, doctor’s office, health insurer?

If Yes The FTC’s Health Breach Notification Rule does not apply. (You don’t have to now answer Question 10.)

If No FTC’s Health Breach Notification Rule might apply. Go to Question 10 to validate. 

Question 10: Are you providing health records directly to customers? 

If Yes You are personal health records (PHR) provider or in related roles. Thus,  FTC’s Health Breach Notification Rule applies to you. 

If No The FTC’s Health Breach Notification Rule does not apply.

So, now when you know which laws apply to your mobile app, let’s discuss each of these laws in detail. 

USA Healthcare Laws in Detail 

1) HIPAA Act

HIPAA talks about healthcare compliance rules in 4 major categories.

  • HIPAA Privacy Rule 

The HIPAA Privacy Rule ensures the privacy of personal information of patients and their family members. It makes it compulsory for healthcare providers to put strict measures in effect to collect, share and save the ePHI safely. 

HIPAA Privacy Rule also sets limits on the uses and disclosures of data without the permission of users. This rule enables users to examine and obtain a copy of their health records. 

  • HIPAA Security Rule

The HIPAA Security Rule promotes the technical and physical measures to assure the confidentiality, integrity, and availability of electronic PHI. 

  • HIPAA Breach Notification Rule

Under the HIPAA Breach Notification Rule, healthcare providers must identify the data breach and provide notification or make affected users, the Secretary of HHS and even the media (in some cases) familiar with the breach incident. The HHS has developed the online portal to submit the breach incident details. 

  • HIPAA Omnibus Rule

The HIPAA Omnibus rule was finalized by HHS in 2013. According to rule, business associates are now directly liable for any non-compliance. It also controls the use of ePHI for marketing purposes. 

2) Federal Food, Drug, and Cosmetic Act (FD&C Act)

The FD&C Act is enforced by the FDA. It governs the safety and effectiveness of medical devices and mobile apps. The aim to enforce this rule is to ensure that all medical devices which include the mobile apps are safe for public use. FDA has developed a category named the mobile medical app. If your app is a mobile medical app, your app does not fall under this jurisdiction. 

3) Federal Trade Commission Act (FTC Act)

FTC Act is enforced by the Federal Trade Commission. It restricts the false claims over the app’s safety, privacy and performance. In other words, it defines regulatory protocols to cope up with unfair claims in businesses and issues related to privacy and general data security challenges. 

4) FTC’s Health Breach Notification Rule

FTC’s Health Breach Notification Rule makes it mandatory for healthcare providers to provide notifications if they encounter a data breach. Under the FTC’s Health Breach Notification Rule, healthcare providers who experience a data breach must notify the affected individuals, media and FTA.  This rule does not apply to healthcare providers covered by HIPAA. 

Why are regulations important in healthcare?

There are two major reasons why healthcare regulations are so important. 

  • Prosperous Industry 

As far as the data is concerned, healthcare is the most prosperous industry. In addition to the personal information of patients and their family members, a healthcare device, mobile app or software collects sensitive financial information of the patients. The large number of people who access healthcare services and share their crucial personal and financial information also makes it important to impose rules to ensure data security and data privacy. 

  • A Soft Target 

Though the healthcare industry is one of the late adopters of modern technologies, it adopted it very rapidly. Because of the rapid adoption, it failed to address the gray area of the technologies which resulted in a lack of cybersecurity and even IT system knowledge among users interacting with those modern technologies. Such users are the greatest threat to healthcare data and the greatest gift to intruders! 

How does a healthcare compliance consultant navigate you through US healthcare laws complexity? 

What does the government do? – Tell you to follow regulations. 

What does a healthcare compliance consultant do? – Show you the methods to follow regulations. 

Healthcare laws implementation is more important than understanding healthcare laws. You should not only understand the HIPAA privacy laws. You need to really develop the healthcare app in such a way that it ensures data privacy. 

A healthcare compliance consultant carries out a deep-dive analysis of your app, finds security gaps and assists the development team to fill those gaps in order to develop a HIPAA compliant healthcare app. 

Here, I would like to share a case study that talks about how my healthcare compliance teams helped a development firm to identify and fill 47 security gaps in the healthcare app. 

We are a full-strength healthcare app development company for a reason – we accommodate healthcare compliance experts, EHR integration engineers, and app developers & designers.  


Our recent telehealth app development project featured in Collision Conference

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