Tech companies need to continuously review how they gather and keep user data because there are an increasing number of health apps available on the market and new privacy regulations. If you are just beginning the process of developing a healthcare app, you need to know what “HIPAA compliance” means.

Appic Softwares developed several well-received HIPAA-compliant applications for our customers. We developed a handbook explaining the purpose of HIPAA standards and providing answers to frequently asked concerns about developing HIPAA-compliant software from the ground up, based on our experience. Finally, as a bonus, locate a HIPAA-compliant app checklist. Now let’s move!

What is HIPAA

The Health Insurance Portability and Accountability Act is referred to as HIPAA. To safeguard patient privacy and medical records, the United States Congress passed it in 1996.

Ensuring the confidentiality of personal health information is the primary objective of HIPAA. HIPAA so covers PHI (Protected Health Information), which includes any data that can be used to identify a patient, including name, date of birth, SSN, and phone number.

Users of mobile apps that comply with HIPAA regulations are certain that their private information is securely protected. To preserve PHI data protection and comply with HIPAA regulations, HIPAA-covered companies need to have a business associate agreement with each partner.

HIPAA fundamentals

This article contains all the information you require regarding HIPAA and compliance software development. However, if we had to condense it into just two points, those would be them:

Patient confidentiality is safeguarded by HIPAA regulations, which are American law and with which all organizations operating in that country are required to comply.

HIPAA lexicon

Although it may seem apparent, developing software that complies with HIPAA introduces many new vocabulary and meanings. Some of these expressions may be completely foreign to you, even if you have project experience in the healthcare industry or come from a medical background. These are definitions for the top five HIPAA-related terms.

Term Definition
Authorization Signed permission that allows covered entities, such as doctors and hospitals, to disclose patient information.
Covered entity partners and business associates who are subject to restrictions and who gather confidential patient data.
Non-covered entity a person, organization, or enterprise that DOES NOT offer health care.
EHR, electronic health records Electronic version of patient’s medical history.
PHI-protected healthcare information Personal and health data of a patient that is protected under HIPAA.

HIPAA-protected health information (PHI)

All data that can be used to identify a patient is considered protected health information. In summary, any information that is specific to a patient, such as their name, SSN, personal number, or other data. Later in this piece, we’ll go into more detail about this.

Entities covered by this policy

There may be more clarification needed for this phrase as well. Covered entities are defined as:

health plans, clearinghouses for healthcare, and healthcare providers who send any health information electronically about transactions for which HHS has established guidelines.

To put it briefly, among the covered entities are insurance companies, doctors’ offices, dentist offices, chiropractor offices, and hospitals. Under HIPAA, every covered entity is subject to the privacy regulation.

Entrepreneurs and product owners must comprehend that the majority of health apps are not considered covered businesses under the HIPAA security rule. They must still cooperate, though.

Why are medical apps required to comply with HIPAA?

HIPAA privacy regulations are significant for reasons other than legal ones. They are crucial since they genuinely safeguard individuals and provide advantages to hospitals and patients alike. Let’s take a deeper look.

Regarding patients

For patients, trust and HIPAA go hand in hand. A physician’s compliance with HIPAA ensures the confidentiality and integrity of all patient information.

For medical professionals

Healthcare providers benefit from standards such as HIPAA regulations, which help them standardize services, maintain data integrity, increase process efficiency, get rid of fraud, and lower the danger of data breaches. Furthermore, HIPAA fosters confidence between a patient and a physician. Which would you prefer—visiting a facility with a HIPAA certificate or somewhere where there are no assurances regarding the security of your data?

For entrepreneurs just starting out

Repercussions for noncompliance can bankrupt early-stage companies. Disregarding HIPAA standards can result in fines ranging from $100 to $50,000 for each infraction, with an annual maximum of $1.5 million. There may even be jail time for some infractions.

It is essential to understand HIPAA regulations if you don’t want to go afoul of the law, which nobody does.

What does HIPAA compliance entail for developers creating health applications?

Creating an app that complies with HIPAA requires meeting three different sorts of requirements: administrative, physical, and technical safeguards. They’re all about controlling data exchange and access management. Let’s go over each HIPAA regulation in great depth and talk about potential app safety precautions.

Administrative prerequisites

These speak about internal policies that startup managers, medical facilities, and other healthcare providers can put in place before developing an app to protect user privacy and security. For instance, doing risk assessments and frequent staff training. Among the administrative security measures are:

Frequent security reminders; Penalties for noncompliance with HIPAA laws by employees; HIPAA supervisors assigned to a team.

Physical protection

Physical protections are actual regulations that prevent unauthorized physical access to networks, workstations, buildings, and computer servers. Monitoring data access in a HIPAA-compliant app is their primary objective to avert potential violations and unauthorized users. These safety precautions for developing software compliant with HIPAA regulations comprise:

  • Building security; access control, including visitor log-in and door passes; emergency procedures in case something goes wrong;
  • protocols for disposing of devices and data.

technological protections

Device theft is the primary cause of HIPAA violations since it gives thieves access to all of the data on your phone. Technical specifications guarantee that private data in HIPAA-compliant software is protected on the back end and will stay private even if your device is stolen.

Technical protections in HIPAA-compliant app development contribute to a decrease in fraud and identity theft as well as improper use of data. Among them are:

  • distinct user identifier (such as an account number or distinctive name);
  • Protected data transfer networks; automatic logout owing to inactivity; emergency access protocols; encryption of electronic protected health information;
  • routine examination of information systems;
  • handling of passwords;
  • Authentication with two factors to confirm app opening.

What happens if you fail HIPAA compliance 

There may be serious repercussions if you do not safeguard HIPAA privacy for consumer health information.

First, as required by law, you must inform users about the breach, identify the information that was compromised, and outline any possible dangers. The startup is also required to notify media outlets if it affects more than 500 individuals. Just consider the potential negative publicity this could generate and the potential harm it could do to your company.

Second, the owner of the HIPAA application may be subject to fines and penalties that will burden financial management, particularly for fledgling companies.

Planning and being aware of HIPAA compliance are necessary to avoid this.

What data is subject to HIPAA regulations

PHI, or protected health information, is mentioned in the statute. Under HIPAA regulations, any information that can be used to identify a specific user is safeguarded. It consists of:

Names If combined with consumer health information, full name, first or last name, and initials are protected under HIPAA standards.

Every geographic identifier

anything that is not a state, such as your county, city, or neighborhood. One exception exists, through a zip code’s initial three digits. Thus, the address or birthplace of the user would be protected.

Dates Every date—aside from the year—has a direct connection to a user. For instance, the date of birth, the date of death, and the date of admission or release.

Numbers to call

When you receive spam calls, have you ever wondered how they obtained your phone number? Not from your healthcare practitioner, please, as that would be a major breach of HIPAA. For those of you who are old enough to recall, a fax number is also regarded as a component of the PHI-covered companies.

Email addresses

Email is protected by HIPAA as it might be used to identify a patient.

Social Security number

Identity theft and other major repercussions might result from Social Security numbers being compromised.

Numbers from medical records

The six-digit number can be found on the majority of medical records, including referrals, visit summaries, and bills. It facilitates access to patients’ electronic records for healthcare practitioners.

Details about health insurance

Provider name, patient ID, and group number are all private information that needs to be secured under HIPAA.

Number of accounts

During a medical appointment, healthcare organizations assign this number, which is likewise protected by HIPAA.

Numbers from certificates or licenses

Physicians are also protected by HIPAA, as the regulations governing compliance apply to their professional and educational records.

Details about the vehicle

A driver’s license number, a license plate number, or an automobile’s serial number are examples of covered entities.

Serial numbers and device identifiers

The serial numbers of users who use medical devices—such as insulin pumps or heart rate monitors—would likewise be regarded as private patient information.

Web URLs: Every URL that has the potential to be connected to patients should be secured. When developing an app that complies with HIPAA, don’t ignore it.

Internet Protocol addresses

An IP address can be used to identify a device that uses your mHealth app and, in the wrong hands, be linked to a person’s laptop or smartphone.

biometric information

Biometric data scans are often used by healthcare organizations to associate a particular user with an account. Since each person’s fingerprints are distinct, all information added by a patient to their account will remain private. Fingerprints, retinal prints, voice prints, and other biometric identifiers are among the covered entities here.

Images or videos

This covers any image that displays a person’s entire face as well as any image that contains personally identifiable information (PHI), such as a name, initials, or patient number.

Any other identifying information

Every other trait and special code can identify particular people and provide their health information.

Should your mHealth app be HIPAA-compliant

Not every mobile and web solution for healthcare needs to comply with HIPAA. Since most yoga, meditation, and health apps only require personally identifiable information for personal use, they would not be covered by the privacy act. Sharing it with healthcare providers is not intended.

Only platforms that exchange your medical information with “covered entities”—other parties, such as physicians, dentists, hospitals, and health insurance companies—are subject to the HIPAA Act. Their software needs to be HIPAA compliant.

You must respond to three inquiries regarding your healthcare app to determine whether the law applies to your startup:

There are other US data protection laws.

Like the GDPR in the European Union, the United States does not have national privacy and data protection legislation. However, there are numerous intricate rules about particular categories of data. Let’s examine a few of them that relate to your mobile application.

FTC Regulation

Users are shielded from “anticompetitive, deceptive, and unfair business practices” by the Federal Trade Commission Act (FTC). In essence, it calls on you to alert users when their data is compromised and to be open and truthful with them about how you handle their information.

State legislation

There is state-specific legislation about data privacy. The SHIELD Act, for instance, was introduced in New York. It applies to any app that has a resident of New York’s private information. To put it briefly, if you have at least one user from the city, the SHIELD Act probably still applies to you even if you don’t operate in New York. According to the statute, specific administrative, technological, and physical data protection measures must be implemented by mobile apps.

The Consumer Privacy Act (CCPA) is another data privacy regulation that applies to residents of California. Users can request the deletion of information, know what information an app collects, and choose not to share their data with other parties under this legal framework.

How to apply HIPAA to your mobile app development

Understanding HIPAA regulations is essential for startups in the healthcare sector to prevent severe fines and penalties. We advise taking these four actions to make your app HIPAA compliant and to guarantee that the personal health information of your users is secure.

Make an investigation

Prioritize your education by becoming knowledgeable about all applicable laws, HIPAA compliance, and other data privacy rules that may apply to your app. Your startup will have to pay the price in terms of both money and reputation if your contractor makes a mistake. Learn about the topic and conduct your study in advance to avoid this from happening. You can get all the information you require online.

Analyse patient health information

Examine the kinds of personal data you use with your software development team, and determine what features and security measures are required for the solution to meet HIPAA regulations. To make sure you get everything, you may also utilize our checklist.

If necessary, use HIPAA-compliant advisors.

There are outside businesses that can assist with HIPAA compliance for your startup. For instance, they assist with staff training and professional direction, as well as the gathering and storage of patient data. These businesses consist of, for instance, audit and HIPAA consulting firms.

Collaborate with seasoned developers

Due to its ability to reduce error rates, a competent team is essential for developing apps that comply with HIPAA regulations. Make an informed decision, evaluate the portfolio of your potential developer, and read testimonials from prior customers. Verify that the staff has prior experience in the field; the healthcare sector is a critical one where mistakes cannot be tolerated.

What is the price of creating an app that complies with HIPAA?

The crucial query at hand is how all of this affects your product’s pricing and how much it typically costs to create HIPAA-compliant apps.

Let’s examine the financials of a project we created that complies with HIPAA.

Stage What are we doing Est. hours Est. weeks Est. cost
Initial meeting Discuss the idea of your app 1 day No costs
UI/UX design Map users’ journeys, create interface mock-ups 125 hours 5 weeks $6 300
Software development Work on building your healthcare app 860 hours 10 weeks  $38 700
QA Testing Find and fix bugs 300 hours In parallel with the development $6 000
Project management Handle administrative duties and oversee software development projects. 16 (in weeks) During the whole project $4 250

Creating an app that complies with HIPAA regulations will run you about $55,250 and take about five months.

5 steps to Make HIPAA compliant apps

Step 1: Have a good idea first. The foundation of a HIPAA-compliant mobile app is an original concept that will make your product stand out from the competition. Consider your target audience and how your solution will benefit them before you plan the platform. Your user is who? What distinguishes you? How will you monetize your app? To develop the concept into a business plan, these are the initial exploration questions.

Step 2: Assemble a group. Selecting the ideal developer is important. A knowledgeable and competent staff can support you in achieving the intended outcomes, help with data privacy analysis, and fortify your concept for HIPAA-compliant software. When selecting a developer, take your time, look over the portfolio for pertinent examples, and confirm the references from prior customers.

Step 3: Determine whether your concept qualifies for HIPAA-compliant applications. As we have stated, the HIPAA Act does not apply to every application that contains medical data. Depending on what data you get and how you handle it, yes. Check all the prerequisites before developing an app that complies with HIPAA.

Step 4: Construct an MVP. A valuable tool for startup entrepreneurs is an MVP. It is an acronym for a minimal viable product, which is a tool for testing ideas on actual customers. This stage should not be confused with a draft or a prototype: an MVP is a working product that has had its feature set reduced. Still, they’re sufficient for a user to finish a journey and give you feedback.

Step 5: Enhance and release the item. It’s time to develop and advance once you’ve analyzed data and gotten customer feedback. The group will assist your HIPAA-compliant app after launch, plan future healthcare software development and potential scale-up, provide updates, and resolve any problems.

Conclusion

As you venture into the realm of healthcare app development, consider partnering with Appic Softwares, a leading provider of innovative and tailored solutions in the $10,000 to $80,000 range. After producing high-quality healthcare apps for years, Appic Softwares combines technological experience with market insights to realize your vision.

Contact us today to begin your journey towards creating impactful and transformative healthcare solutions.