March 25, 2024

HIPAA-Ready Apps: Navigating Compliance for Healthcare Solutions

Elena Pashkovskaya

Technical copywriter

Healthcare

HIPAA-Ready Apps: Navigating Compliance for Healthcare Solutions
March 25, 2024

HIPAA-Ready Apps: Navigating Compliance for Healthcare Solutions

Elena Pashkovskaya

Technical copywriter

Healthcare

HIPAA-Ready Apps: Navigating Compliance for Healthcare Solutions

As the world market for mobile health apps is expected to surge from $40.2 billion in 2021 to $340.5 billion by 2030, mobile apps' HIPAA compliance is gaining more significance in software development. Health Insurance Portability and Accountability Act (HIPAA) targets sensitive data, and its requirements are obligatory in software development for specific applications. HIPAA-compliant software guarantees that users' data remains secure, increasing trust and preventing the disclosure and misuse of private information.  

Let's unravel the HIPAA topic and get a clear view of how to make a HIPAA-compliant app.

Key Takeaways

  • HIPAA compliance ensures that patients' protected health information is created, transmitted, maintained, stored, and used safely and not disposed of by unauthorized personnel.
  • HIPAA compliance is crucial for mHealth apps, as it protects personal health data stored and used on the device. With the growing demand for health-related apps, the amount of data will continuously grow, poisoning the risk of data theft or misuse. HIPAA conditions and their obligatory nature safeguard protected health information.
  • HIPAA-compliant app development calls for imposing particular requirements for the development process and fulfilling HIPAA regulations for the app itself.
  • Not all mHealth apps require HIPAA compliance. The main criteria for such compliance are the client's status (covered entity or business associate) and the type of data — whether or not it is protected health information.

 

What Is HIPAA Compliance?

Health Insurance Portability and Accountability Act, put into practice in 1996, is the cornerstone legislation governing the protection of protected health information (PHI). HIPAA compliance means legislation enforcement of the HIPAA, which ensures medical data privacy and security.

Two principal regulations supplement HIPAA:

  • The HIPAA Privacy Rule establishes national norms to safeguard individually identifiable health information, particularly when transmitted electronically (e.g., medical records, health insurance claims).
  • The HIPAA Security Rule protects the confidentiality, integrity, and availability of electronic protected health information (e-PHI) created, received, used, or maintained by covered entities (e.g., healthcare providers and health plans).
Under HIPAA, covered entities include Healthcare providers, hospitals, clinics, pharmacies, healthcare business associates, health insurance organizations, and healthcare clearing houses.

Before September 2013, only covered entities like doctors, hospitals, and insurers were subject to the regulations of the HIPAA. However, the Final Omnibus Rule Update expanded the scope of HIPAA compliance. Any entity storing, managing, recording, or transmitting PHI must comply with HIPAA regulations. It includes developers of medical apps, who are responsible for ensuring their apps are HIPAA compliant if they handle PHI. Under HIPAA, there's no excuse for neglecting data security. Protecting PHI is mandatory for any entity handling such information.

Why HIPAA Compliance Is Crucial for Mobile Apps

Does HIPAA apply to mobile apps? Certainly yes, as any other software that deals with protected health information.

Today, more and more people use smartphones and rely on telehealth and mHealth applications — the US mHealth app market is projected to grow at a CAGR of 11.40% and reach $86.15 billion by 2032, stressing the growing importance of mHealth apps in the American healthcare landscape.

The US mHealth apps market shows continuous growth from 2022 and is expected to reach $86.15 billion in 2032.
Mobile Health Apps Market Size. Source

Personal data security and privacy become increasingly crucial for healthcare providers and software developers of healthcare mobile apps and wearable devices.

Data breaches and leakage are the primary challenges associated with healthcare apps. As ePHI contains such data as social security numbers, account numbers, and biometric identifiers, it opens vast possibilities for misuse when it is in the wrong hands. Criminals can target medical records to commit identity theft, fraudulent obtaining of medical services, or performing fraudulent tax returns. HIPAA compliance in mobile app development helps to keep data safe and secure.

Physical phone security is another point of concern. In case the device is lost or stolen, even from the developers' point of view, the measures must be taken to ensure that even then, the sensitive data from mHealth apps is safeguarded. The main measures include preventing unauthorized access and securing access to physical devices where PHI resides.

Overall, creating mobile apps with HIPAA compliance can increase customers' loyalty and trust, improve data security, reduce the risk of legal actions, and bring a competitive advantage to the market.

HIPAA Compliant App Development

HIPAA-compliant app development has peculiarities that are hard to handle for professionals lacking relevant experience. Though the stages of development are the same as for any other software, HIPAA compliance starts from the beginning of the development process and emphasizes data security at all stages.

The main steps include:

  1. Define that your app must be HIPAA compliant, i.e., you are building an app for a covered entity or business associate and tackling PHI. Determine the critical functionality and target audience of your mHealth app.
  2. Launch risk assessment to determine your future app's risks, such as unauthorized access or PHI disclosure.
  3. Describe HIPAA app features. What PHI will be used, and how will data be transferred, stored, and utilized?
  4. Develop policies and procedures. This documentation addresses the potential risks and guides all staff involved in HIPAA-compliant app development.
  5. Introduce a secure development lifecycle — the established framework encompasses well-defined stages that integrate security considerations throughout the development process, from the initial conception to deployment.

If you do not have in-house resources experienced in eHealth apps, get professional help. You can refer to a HIPAA-compliant app development company and use their expertise to create a mobile app.

Things to consider while building a compliant app:

  • Authentication and encryption: according to HIPAA, all transferred and stored ePHI must be encrypted. HTTP protocols and SSL should be used to transfer patients' data and passwords safely. Data safety also implies introducing strict access control, logins, and PHI access for authorized personnel only.
  • Integrity: when developing HIPAA-compliant mobile apps, robust security measures must be implemented to protect the collection, storage, and transfer of sensitive health information, preventing unauthorized access or modification. Ensure the system can detect and report any unauthorized data breaches.
  • Disposal: archived and expired data must be permanently disposed of with no option for retrieval to prevent data leaking.

Altogether, HIPAA-compliant app development is subject to the regulations set in the Law, with the introduction of a secure development lifecycle and permanent control over the fulfillment of policies and procedures.

Health App Use Scenarios & HIPAA

Now, we will look at one health app use scenario when HIPAA compliance is obligatory and later find out about apps not covered by HIPAA. Not all health-related mobile apps require this compliance.

Case:

Following their doctor's instructions, a patient downloads a health app on their smartphone. This app, developed in collaboration with the healthcare provider, allows various services to manage the patient's health remotely, including remote counseling and patient messaging. Information the patient enters in the app is automatically added to their doctor's electronic health record.

Resolution:

In this case, the app must be HIPAA compliant, as it is developed at the request of a covered entity (healthcare provider) and stores, transmits and processes PHI.

Let's move on to the particular cases of HIPAA-compliant apps use and look at their features and functionality.

HIPAA-compliant texting apps

By default, the text messages we use daily are generally not HIPAA compliant. You cannot transfer patients' data via SMS, instant messages, or e-mail. For these purposes, special HIPAA-compliant mobile apps are developed.

The typical features of HIPAA-compliant apps include user control, access management, activity tracking, data encryption, threat detection, real-time alerts, auto log-off, EHR integration, and more. Examples of compliant mHealth texting apps are Rocket Chat, TigerConnect, and SimpleTexting.

Will be a good idea to consider using the following features:

  • Message lifespan
  • Mass texts
  • Two-way messaging
  • Message recalling
  • Priority messaging

HIPAA-compliant mobile texting apps offer personal data security for easy and secure communication between healthcare providers and customers.

HIPAA-compliant video chat apps

When messaging is not enough, you can also make an appointment and discuss the concerns with your doctor face-to-face via video consultation. HIPAA-compliant video chat apps enable remote counseling and connect healthcare specialists. Video conferencing, EHR management, and appointment scheduling are the core features of this type of software.

The particularity of the security approach towards HIPAA-compliant video chat mobile applications is video encryption. Some prominent examples of such software include VSee, Doxy, TheraNest, Zoom for Healthcare, and SimplePractice.

Features to consider for the video chat mobile app:

  • Virtual waiting room
  • Password hashing
  • Therapy notes
  • Billing assistance
  • Screen sharing

HIPAA compliance for video conference mobile apps is reached through the exact requirements of messaging apps with an allowance for video data format.

Apps with image-sharing

Medical images can take different forms, such as MRI, CT x-ray scans, etc. HIPAA-compliant image (or any other file) sharing application allows secure data sharing only with authorized parties. Common image-sharing violations in healthcare include sharing unencrypted and unprotected patient photos and using patient photos without permission. 

HIPAA compliance ensures safe and secure image messaging, including storage, transmission, and permanent removal. Examples of HIPAA-compliant image-sharing apps are OrthoPhoto, CaptureProof, and TouchMD Snap.

If you want to build HIPAA compliant image sharing mobile app, consider several features to include:

  • Photo templates
  • Multiple device use in one account
  • Integration with cameras
  • Photo tagging
  • Interoperability with EHR systems

In short, all three types of mobile apps for messaging, video calls, and image sharing are subject to HIPAA and have the exact requirements to comply with. Some apps combine the functionality of all three, enabling messaging, calls, and image exchange, so consider this option for the future HIPAA-compliant app.

Healthcare Apps That Don't Require HIPAA Compliance

Not all health-related applications must be HIPAA compliant. In general, if your application is supposed to be used to transfer PHI to a doctor, it must be HIPAA compliant. The other way to check whether a mobile app is subject to and governed by HIPAA is to find out the app user type (entity) type of information processed.

The entities that require HIPAA compliance include covered entities, such as health insurance companies, healthcare providers, including pharmacies and healthcare clearinghouses), and business associates — persons or entities who handle protected health information for a covered entity.

Specific medical information must be protected and also require HIPAA compliance. PHI includes but is not limited to the patient's name, date of birth, admission date, address, phone number, social security number, or any other ID number etc.

Data subject to HIPAA regulations include patient information, such as name, birth date, phone numbers, e-mails, medical record numbers, account numbers, etc.

That is why telemedicine, EHR, and condition-based mobile apps fall under HIPAA compliance. But if your mHealth app is aimed for personal use and does not carry personal identifiers, it does not need HIPAA compliance. Such apps include diet apps, workout program apps, and IoT fitness apps.

 For example, a woman with a long-term health condition gets a health app on her phone. This app helps her manage her condition. She takes information from her doctor's electronic records through a website where patients can access their information. She downloads this information to her computer and then puts it into the app. She also adds her information to the app herself.

Is the application's HIPAA compliance required in that case? The answer is no. As we can see, the app user obtains her health information from the provider and then makes her input. The app developer does not create, receive, maintain, or transmit PHI on behalf of the covered entity or business associate.

How to Make Your App HIPAA Compliant

Strict adherence to HIPAA requirements, main principles, and safeguards is the key to creating HIPAA-compliant mobile apps. Let's take a look at the HIPAA main conditions for PHI safety.

Physical safeguards: medical devices and media control. Includes network security for data transfer, backend, and non-iOS or Android device protection. Best practices include using multi-factor authentication systems, lock screens, and enabling remote wiping of lost smartphones.

Administrative safeguards: these rules cover how to choose, create, use, and update ways to protect your electronic health information (EPHI) and how they manage their employees' access to it.

Technical safeguards: relates to medical data encryption and transferring. Collecting only necessary data and storing it as long as required is one of the best practices in this area.

The other PHI protection regulations include:

  • Audit Controls Standard: The medical app developer must have the hardware, software, and/or procedures for data access check, including tracking, recording, and analyzing activities in systems that contain ePHI;
  •  Integrity Standard: requires procedures to protect PHI from inappropriate change and destruction;
  •  Access Controls Standard: includes unique user ID in the system, emergency access plan, auto log-off, data encryption, and decryption at all stages of data use or processing.

 Additional points to make your mobile app HIPAA compliant:

1.   Clearly define the security requirements

2.   Apply limitations to using and sharing PHI

3.   Gain access control

4.   Work out a clear privacy policy

5.   Provide secure data transmissions

6.   Use data encryption at all stages

7.   Use suitable PHI disposal

8.   Estimate audit controls

9.   Adhere to secure mobile app development best practices

The development of a HIPAA-compliant mobile app requires following PHI protection standards, principles, and requirements. A HIPAA-compliant app is an app that fulfills the requirements laid out in the document, ensuring health data security and protection.

Developer's Resources

The Law strictly regulates the healthcare industry, and navigation through numerous legal acts can be challenging. Building a health app does not require getting any HIPAA-compliant certificate, as nothing like this exists. However, the developers should do their best to ensure confidentiality and provide data security. Luckily, there are valuable developer resources to help with this daunting task.

Mobile Health Apps Interactive Tool facilitates building HIPAA-compliant mobile apps by offering a quick questionnaire and providing relevant information based on answers. Depending on the case, the tool guides the developers to the information about specific federal legislation that might apply.

Health Information Technology. The FAQ provided by the US Department of Health and Human Services addresses the most topical requests towards HIPAA compliance and ePHI.

Health App Use Scenarios & HIPAA - PDF. The guide describes various mHealth application scenarios and helps app developers understand when they might be classified as business associates under HIPAA regulations.

Access Rights, Apps, and APIs address FAQs about HIPAA rules regarding the right of access, applications, and APIs for covered entities and business associates.

Guidance on HIPAA & Cloud Computing. The guidance helps HIPAA-covered parties, including cloud service providers, understand how to use cloud computing without violating laws.

Remember that it is just a starting point. Thoroughly research HIPAA regulations and seek professional guidance for HIPAA-compliant app development.

Conclusion

HIPAA-compliant software development checklist: learn HIPAA rules, determine which apply to your organization, conduct a risk assessment, decide what data to protect, define responsibilities in the compliance plan, elaborate exhaustive documentation, report security incidents quickly, and regularly check for Law updates.

Developing HIPAA-compliant mobile apps requires a thorough understanding of the regulations and a dedication to ongoing security measures. While it adds complexity to the development process, adhering to HIPAA is crucial for protecting patients' privacy and ensuring the secure management of their sensitive health information.

Consult HIPAA compliance professionals for in-depth guidance and legal advice, especially for complex projects. NEKLO offers healthcare software development services, ensuring that your mobile app will be HIPAA-compliant and feature-reach. We are ready to help you build the software that your customers will love using top-notch technology and expertise.