How to Build HIPAA Compliant Mobile App? Explore Top Healthcare Laws & Regulations Apply to Your Healthcare App in the USA

This is the most simplified blog ever written on developing HIPAA compliant mobile and web app.

And here is what you’ll gain from this blog.

• A complete understanding of USA healthcare laws and regulations
• Find the right healthcare laws that apply to your healthcare app idea.
• Our HIPAA compliant app development execution (which we have been performing for 8+ years.)

So, let’s come straight to the point.

A quick overview of US Healthcare laws and regulations

This is the first and crucial step in order to build a HIPAA compliant mobile and web app.

Because understanding healthcare laws and regulations is essential – if you want to make your healthcare app compliant with all the data privacy and security laws.

So, let’s get started.

1) Who regulates the healthcare industry?

The USA is one of the largest and most flourishing healthcare industries. 

But jumping into it is not as easy as it sounds. 

Multiple healthcare laws and federal approval make it one of the toughest tasks to launch any healthcare app 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.

How to build a HIPAA compliant mobile and web app in the USA?

Developing a HIPAA compliant healthcare app is not rocket science.

What you simply need to do is – identify which healthcare laws and regulations apply to your healthcare mobile and web app idea.

Once you are aware of it, just keep in mind those laws during the app development process – rather say, the coding lifecycle.

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

Question 1: Do you create, receive, and save the 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 or 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 a 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.)

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.

If No, 

FD&C act applies. 

(Go to Question 7 to see if the FDA still gives you an exception.)

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.)

Your mobile app falls under the 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.

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.)

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 on behalf of a hospital, doctor’s office or 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 a 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 that you know which laws apply to your mobile app, let’s discuss each of these 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 the 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 an online portal to submit the breach incident details.

• HIPAA Omnibus Rule

The HIPAA Omnibus rule was finalized by HHS in 2013. 

According to the 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 mobile apps are safe for public use. 

FDA has developed a category named the mobile medical app. 

So, if your app is a mobile medical app, your app does not fall under this jurisdiction.

3. Federal Trade Commission Act (FTC Act)

The FTC Act is enforced by the Federal Trade Commission. 

It restricts false claims over the app’s safety, privacy and performance. 

In other words, it defines regulatory protocols to cope 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.

How do we build HIPAA compliant mobile and web app?

Based in Ontario, we are a healthcare-focused IT company.

In other words, we only entertain healthcare IT projects for startups, hospitals, clinics, organizations and individuals.

What distinct us from the rest is that – we accommodate dedicated compliance experts for each project we perform.

And our lead compliance specialist has designed a result-oriented plan to build HIPAA compliant mobile app in the USA, Canada and beyond.

Following is the entire process.

1. Identifying the scope

We first determine the need for HIPAA compliance.

It may include – technical, administrative and physical safeguards.

2. Asset location, asset identification and risk analysis

It is important to have a clear understanding of the scale of healthcare app infrastructure.

Without knowing it – it is almost impossible to identify how much control your app requires to protect your app against cyber attacks.

But this step helps us to identify each security loophole your app possesses.

3. Implementation

Here, our HIPAA compliance experts work with the developers' team.

They keep their bulls-eyes open during the entire development lifecycle along with ensuring that all your technical and administrative compliance requirements are met.

4. Compliance auditing

This is a method to make sure that,

• A successful implementation
• Achieved safety standards

Once this audit is done, you can claim that your mobile or web app is HIPAA compliant.

5. Risk assessment

Healthcare apps are always surrounded by cyber criminals – there is no doubt about it.

Thus, it is important to perform a risk assessment on a regular basis in order to identify and fulfill the security gaps in your app.

This approach adds an extra layer of security to your app and enables you to avoid data breaches and hefty fines from the federal government.

What is the importance of developing a HIPAA compliant mobile and web app?

There are two major reasons why healthcare regulations are so important for healthcare app development.

• 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, they adopted them 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 for developing HIPAA compliant mobile and web app?

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. 

But you need to 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, we would like to share a case study that talks about how our healthcare compliance teams helped a development firm to identify and fill 47 security gaps in the healthcare app!

You must also read: How to Hire Best HIPAA Compliance Consultant in USA, Canada?