The ultimate guide on how to make your application HIPAA-compliant.

HIPAA Security: Steps to Make Your App HIPAA-Compliant

It is not a secret that you should pay attention to HIPAA security regulations while developing a healthcare application. However, handling all the details may turn confusing and lead to setbacks or penalties. For example, there was a case in 2015, when the government imposed a $218.000 fine on a Massachusetts hospital for their healthcare application demonstrated not fully compliant with HIPAA security standards. Even more, violating HIPAA security may crash your business.

In this post, OpenGeeksLab will uncover how to avoid data protection troubles and build an app up to HIPAA security standards.

HIPAA Security Act in a Nutshell

Everything you should know about HIPAA security requirements and how they differ from other security standards.

Healthcare mobile app development is on the rise now because of the novel COVID-19 pandemic. Many hospitals and private practitioners move online to ensure fast and secure medical help. The demand for healthcare applications has significantly increased during 2020, triggering a real boom in the eHealth business industry.

Numerous data security standards regulate medical and healthcare app development, depending on the target region:


The primary standard for eHealth software in the US is Health Insurance Profitability and Accountability Act (HIPAA). It was passed in 1996 to regulate patient’s data and insurance detail protection. The HIPAA Privacy Rule and the HIPAA Security Rule were passed as the HIPAA additions to secure electronic data recording and transfer. The first complete HIPAA edition gave guidelines only to covered entities: hospitals, private practitioners, insurance agencies. In September 2013, the law was revised, and the amendments covered all entities involved in Protected Health Information (PHI) recording, processing, or storage as HIPAA subjects. Thus, if your healthcare application deals with PHI, you must ensure it conforms to HIPAA security safeguards.

However, HIPAA compliance remains the leading one for mobile app development, there are other regulations that may influence the success of your idea. For instance, if your healthcare application concept deals with medicines or medical equipment supply chain, consider the Food and Drug Administration (FDA) compliance. FDA regulates the process of pharmaceuticals, medical devices, veterinary medicine, and allergenic products manufacturing and distribution, so if you aim at delivering, for example, hand-made cosmetics, make sure it meets the standards.

There also exist local cybersecurity guidelines like the California Consumer Privacy Act (CCPA), which regulates the usage of customer’s private data across California state. So, if you aim at distributing your application in California, ensure it corresponds to CCPA requirements.

Besides, to prove your application innovative and secure, you should think over the National Institute of Standards and Technology (NIST) compliance. NIST does not regulate something or impose fines, though making your app NIST-compliant is a high-quality mark.

The EU

If you launch your medicare application across European countries, it must be compliant with the General Data Protection Regulation (GDPR). The law passed in May 2018 seems even stricter than HIPAA safety rules. GDPR regulates the usage of any customer’s data (including PHI for healthcare software) and presupposes severe penalties for any violation.

Besides, you must assure your app Network Information Service (NIS), which establishes a standard cybersecurity level for informational and network systems.

Like NIST, the International Organization for Standardization (ISO) does not control safeguard compliance, though designing your application ISO compliant makes it meet European quality standards.


The Personal Information Protection and Electronic Documents Act (PIPEDA) embraces Canada’s major personal data use rules. It covers all for-profit entities in all Canadian territories, excluding Alberta, British Columbia, and Quebec.

However, if you create a health-related application, PIPEDA rules operate only across Ontario, New Brunswick, Nova Scotia, Newfoundland, and Labrador. Other territories have passed their local laws regulating medical data protection, so developing a healthcare app for Canada should be careful with provincial standards.


The leading Australian data security law is called the Federal Privacy Act 1988 (Privacy Act). It regulates customer information (including PHI) usage by Australian Government agencies and private companies with an annual turnover of more than $3 million. Apart from federal law, there are also state and territory laws regulating minor details depending on location.

However, knowing the standards is not enough for a successful application launch, as you should also know when your product is subject to these guidelines.

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When Does Your Application Become Subject to HIPAA Security Standards?

Typical cases of HIPAA security compliance being a must.

There are two primary criteria to define whether your app must follow HIPAA compliance requirements: the type of entity and the type of data used. According to entity type, we differentiate:

1. Covered Entities

Covered entities are healthcare organizations that deal with electronic medical records (EMR) or electronic health records (EHR) standardized by the Secretary of Health and Human Services. They commonly involve health plans, healthcare clearinghouses, healthcare providers, both hospitals, and private practitioners.

2. Business Associations

Business associations are the organizations that collect, store, process, or transfer data on the behalf of covered entities. They include lawyers, software providers, cloud storage providers, email encryption providers, accountants, billing firms, and other service providers for healthcare organizations. To support HIPAA safeguards, a covered entity should make an official agreement with a third-party agency, making it a business association.

Under data type, we primarily mean PHI, as it is HIPAA’s central point of interest. PHI consists of two parts: medical information and personally identifiable data. Medical info includes records about healthcare details like diagnoses, treatment, prescribed medicines, while personally identifiable data covers names, addresses, payment details. Only if put together they are subject to HIPAA security requirements.

Why HIPAA Security Violations May Crash Your Business?

Here we will unlock common penalties imposed onto HIPAA rules breakers.

For business success, both parties (healthcare providers and patients) should understand and follow HIPAA security requirements.

1. What Must Patients Know?

EHealth users should know that no entity, either covered or business, can’t use or transmit private health information to third-party agencies or stakeholders. Before performing any disclosing or sending forward operation, an entity must inform a patient and ask for his/her consent. Depending on the data privacy policy and data usage terms agreed with patients, the procedure may be one-time or repetitive.

2. What Must Healthcare Providers Know?

Healthcare providers, above all, must understand that severe fines follow any HIPAA security violation. Irrespective of their status, all covered entities and business associations must assure a high HIPAA security compliance level.

Despite HIPAA violations’ peak fell on 2010-2013, sad statistics show multiple healthcare organizations still suffer from penalties. The fines imposed for HIPAA violations vary from $100 to $50.000 depending on the reason for noncompliance and violations severity. The maximum possible fine is $1.5 million per year.

HIPAA rules violations commonly occur as business owners may not be aware of possible threats and pitfalls on the health app development route. However, if you know the challenges to overcome, nothing can stop you from creating your dream application idea.

Common Challenges You Must Overcome to Make Your App HIPAA-Compliant

Let’s take a look at notable pitfalls to avoid while following HIPAA security requirements.

When you jump into building an application that should satisfy HIPAA security requirements, such a routine can turn challenging. Hence, you should be aware of possible troubles ahead to minimize them and make your business succeed faster. It would be advantageous if you consider these issues on the way of developing a HIPAA-compliant healthcare app:

1. Physical HIPAA Safeguards

Physical safeguards hold control over data safety on local or cloud servers. It also gives instructions on-device protection from unauthorized access.

2. Technical HIPAA Safeguards

Technical safeguards concern technologies you use to make your healthcare application protected. HIPAA requirements do not contain a detailed list of technologies to use, though it commonly embraces user authentication, access control, encryption, etc.

3. Administrative HIPAA Safeguards

Administrative safeguards cover supervising established measures and employee behavior management.

To make HIPAA-compliant healthcare app development smooth and efficient, you should follow the steps from the following HIPAA security rule checklist:

1. Assess Initial Risks

Risk assessment algorithms differ for every other case depending on the organization type, its size, capabilities, and process complexity. Risk analysis typically comprises defining weak places in PHI protection. It also checks whether the whole safety system works in the right way and regards HIPAA security requirements.

2. Reduce Current HIPAA Security Compliance Risks

Possessing the initial risk analysis results, you should develop a plan of system corrections. Trace logical bounds and start from ground problems to cope with the derivatives. Tackle minor issues first; starting from essentials may turn ineffective as first steps because they require more time and effort spent.

3. Provide Reliable Risk Management Software

Adopting reliable risk management software is a vital step for long-term business success. Dealing with HIPAA security, you should continuously monitor possible risks and threats. You should use automated reports, audit trails, network software monitoring, user management, and other features to ensure your application is safe and secure in terms of customer PHI.

4. Consider Other Standards

Although HIPAA security requirements are most common in the healthcare app development industry, do not forget other standards while building your medical application. Consider your business objectives, services/products you deal with, and distribution area to assure your app complies with necessary rules.

Another critical step while ensuring HIPAA security compliance lies in implementing the proper feature set into your app, like the one given below.

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Must-Have Features Ensuring Your App Being Compliant to HIPAA Requirements

The features to implement if you develop a HIPAA-compliant application.

When developing an application up to HIPAA privacy and security rules, pay attention to the software features you implement. Standard options to improve your healthcare app’s data protection level include:

1. Access Limitations

PHI access limitation allows holding control over user activity and assures high data privacy level. As HIPAA privacy and security rules claim that nobody should get excessive patient info, one should assign diverse privileges and prohibitions to different user groups. You may implement it by assigning users unique IDs or varied roles.

2. User Authentication

To ensure the highest level of HIPAA authorization, you should provide individuals with several security options. This includes biometrics (fingerprint, face or voice ID), unique password (at least eight figures including numbers, capital letters, special figures), personal identification number (PIN), and physical authentication means (a token, card, key, digital signature).

3. Data Transfer Security

Secure PHI transferring presupposes usage of HTTPS protocol with SSL/TLS data encryption. It transforms user private and sensitive info into a code useless without a key. Sending PHI-contain files, use SSH or FTPS protocols instead of common FTP.

4. PHI Disposal

According to HIPAA security standards, any PHI no longer in use should be deleted permanently. It means you should carefully delete all user information and its backups not only from general software but (if it is necessary) from devices as well.

5. Data Encryption

Apart from secure data sending, take care of its safe storage. Use encryption not only while transferring PHI but also preserving it on servers. Look for HIPAA security compliant cloud storage or encrypt local ones to protect user privacy.

6. Data Storage and Backup

Data backups are necessary for healthcare providers, as they should have an opportunity to restore patient information in emergency cases (for instance, if the main server has broken down). Healthcare entities should store PHI copies, as well as original records, encrypted on several backup servers.

7. Auto-Logout

If you want to keep it HIPAA security compliant, you should implement an automated logout feature in your local or mobile software. Set a timer for 2-15 minutes depending on the operational environmental protection level. Automatic logout will prevent data leaks in emergency cases (device loss or theft).

8. Audit Reports

Real-time reporting lays a strong basis for adequate data protection. With a streamlined audit system, you can easily track any suspicious actions within your software and timely stop intruders in emergencies.

9. Extra-Security Measures

Mobile devices have additional risks for data safety, as they can be lost or stolen. Encourage your patients to use extra-security measures like screen lock, full-device encryption, or remote data erasure. Offer protected forums or in-built messengers to create a secure doctor-patient communication environment. Do not send PHI in push-notifications as they may appear even on locked screens and accidentally disclose private info.

The features listed above are important but not compulsory. You may either eliminate certain options or add other data security measures to build your perfect healthcare app.

Create Your Own Safety-First Mobile Application with Our Team

HIPAA security rules lay a firm basis for safety-first mobile app development. Making your idea compliant with HIPAA requirements seems challenging. However, you can easily cope with it if you follow guidelines and partner with an expert software vendor.

Our team has expertise in the field as our team has already developed healthcare apps subjecting to HIPAA requirements. OpenGeeksLab always strives for providing high-level data security. We make the safety-first user experience a priority irrespective of the app type we develop. Under every condition, our team ensures user data being equally protected, either we develop a FinTech app or an on-demand service.

Do not feel shy to drop us a line! We will do our best to create a custom HIPAA-compliant application that will make your boldest dreams come true. If you still feel insecure about your idea being subject to HIPAA security standards, book a 15-min consultation with our experts to clarify the disturbing issues right away.

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