Introduction

With the rise of mobile apps that cater to various aspects of healthcare, including fitness, medication management, and telemedicine, ensuring that these applications comply with industry regulations is of utmost importance. One of the most important regulations that health-tech apps should adhere to is the Health Insurance Portability and Accountability Act (HIPAA). 

HIPAA sets standards for protecting patients’ sensitive health information, and failing to comply can have serious legal and financial implications. This article will explore how to design HIPAA compliant app development and secure health tech apps for iOS.

Understand the Basics of HIPAA Compliance

The first step in designing HIPAA-compliant health tech apps is to understand the basic requirements for compliance clearly. This includes understanding what constitutes protected health information (PHI) under HIPAA, the types of entities that must comply with the regulation, the specific requirements for safeguarding PHI, and the penalties for non-compliance.

PHI includes any identifiable health information, including medical diagnoses and treatment plans. Health tech apps that collect, store, or transmit PHI are considered covered entities under HIPAA and must comply with the regulation. The specific requirements for safeguarding PHI include implementing administrative, physical, and technical safeguards to protect against unauthorized access, use, or disclosure of PHI.

HIPAA violations can result in severe penalties, including fines of up to $1.5 million per violation and corrective action plans that require an organization to make significant changes to its privacy and security practices.

In March 2023, a New York law firm had to pay up to $200,000 in fines to resolve HIPAA violations that resulted from a ransomware attack.

Conduct a Risk Analysis

To ensure that your health tech app is HIPAA-compliant, you need to identify potential risks to the privacy and security of PHI. This requires a comprehensive approach to assessing your app’s security posture, including evaluating the risks associated with data storage, data transmission, user authentication, and access controls.

One of the most effective ways to conduct a risk analysis is to use a standardized framework, such as the National Institute of Standards and Technology (NIST) cybersecurity framework. Using a framework will ensure that you consider all relevant risk factors and identify potential vulnerabilities in your app’s security.

What are the Generic Features of a HIPAA-Compliant Application?

A HIPAA-compliant application must have certain generic features to fully comply with the law. These include:

• Encryption: All data stored and transmitted within the application must be encrypted to protect sensitive information from unauthorized access or disclosure.
• Authentication: A secure authentication system is essential for ensuring that only authorized users can access the application. This should include two-factor authentication, complex passwords, and regularly updated user credentials.
• Auditing and logging: The application must maintain detailed audit logs that track all user activity within the system, including who accessed what information and when.
• User access control: Users must be restricted from accessing application areas containing PHI or other sensitive information based on their authorization level and job roles.
• Data privacy policies: The application should adhere to strict data privacy policies regarding how personal health information is handled, stored, transmitted, and destroyed after use per HIPAA regulations.
• Security safeguards: Comprehensive security measures such as firewalls, malware protection, intrusion detection, vulnerability scanning, and periodic penetration testing should be implemented to protect against cyber threats and malicious attacks on the system.

Train your employees on HIPAA regulations

Even if your health tech app has all the necessary technical safeguards in place, it’s essential to ensure that your employees are also aware of their obligations under HIPAA. This includes providing HIPAA training to all employees, including developers, product managers, and customer support staff.

HIPAA training should include an overview of the basic requirements for compliance, including the types of information that are considered PHI, the requirements for protecting PHI, and the penalties for non-compliance. You should also provide training on your specific policies and procedures for safeguarding PHI, including guidance on when and how to report any potential breaches of PHI.

Some of the other essential HIPAA rules that apply to health tech apps include:

The HIPAA Privacy Rule

This rule regulates the use and disclosure of PHI by covered entities (CEs) and their business associates (BAs). It also gives patients the right to access their health information and control how it is used and disclosed.

The HIPAA Security Rule

This rule establishes the technical and administrative safeguards CEs and BAs must implement to protect PHI from unauthorized access, use, and disclosure. The security rule outlines three safeguards: administrative, physical, and technical.

The HIPAA Breach Notification Rule

This rule requires CEs and BAs to notify affected individuals, the Secretary of Health and Human Services (HHS), and, in some cases, the media if a breach of unsecured PHI occurs.

Identify Your Health Tech App’s Purpose

Before designing your health tech app, you must identify its purpose. This involves defining the app’s target audience, the health condition or concern it addresses, and the features that will be included in it. 

You must also determine whether your app is classified as a CE or a BA.

CEs are healthcare providers, health plans, and healthcare clearinghouses that transmit PHI electronically. You must comply with all HIPAA regulations if your app is classified as a CE. On the other hand, BAs are vendors that provide services to CEs that involve PHI. If your app is classified as a BA, you must comply with the HIPAA regulations that apply to BAs.

Conduct a Risk Assessment

A risk assessment is a process of identifying and analyzing potential risks to PHI and the systems that store, process, and transmit it. A risk assessment helps you identify vulnerabilities in your app and implement appropriate safeguards to protect PHI.

When conducting a risk assessment, consider the following factors:

• The type of PHI that your app collects, stores, and transmits
• The systems that your app uses to store, process, and transmit PHI
• The potential threats to the confidentiality, integrity, and availability of PHI, such as unauthorized access, use, or disclosure
• The likelihood and impact of a PHI breach occurring
• The controls that you have in place to mitigate the risks to PHI

Implement Appropriate Safeguards

Based on the results of your risk assessment, you must implement appropriate safeguards to protect PHI. These safeguards include administrative, physical, and technical safeguards.

Administrative safeguards

Administrative safeguards involve policies and procedures that govern the use and disclosure of PHI. Examples of administrative safeguards include:

• Conducting employee training on HIPAA regulations and the security of PHI
• Developing a privacy policy and security policy for your app
• Establishing a process for responding to HIPAA breaches

Physical safeguards

Physical safeguards involve measures that protect the physical security of the systems and devices that store, process, and transmit PHI. Examples of physical safeguards include:

• Implementing access controls such as biometric authentication, keycard access, and security cameras
• Implementing procedures for disposing of electronic media and paper records that contain PHI

Technical safeguards

Technical safeguards involve measures that protect the electronic systems and devices that store, process, and transmit PHI. Examples of technical safeguards include:

• Implementing encryption for data at rest and in transit
• Implementing firewalls and intrusion detection systems to prevent unauthorized access
• Implementing authentication mechanisms, such as usernames and passwords, to control access to PHI

Test and Validate Your App

Before releasing your health tech app, you must test and validate it to ensure it is secure and HIPAA-compliant. This involves testing your app’s functionality, security, and compliance with HIPAA regulations.

• Functionality testing involves testing your app’s features to ensure they work as intended. This includes testing the app’s user interface, navigation, and functionality.
• Security testing involves testing your app’s security controls to ensure they work correctly. This includes testing your app’s authentication mechanisms, encryption, access controls, and other security features.
• HIPAA compliance testing involves testing your app’s compliance with HIPAA regulations. This includes testing your app’s privacy and security policies, breach notification procedures, and other HIPAA requirements.

Maintain Ongoing Compliance

Designing a HIPAA-compliant health tech app is not a one-time process. It requires ongoing monitoring and maintenance to ensure your app remains secure and compliant with HIPAA regulations.

To maintain ongoing compliance, you must:

• Monitor your app’s security controls to detect and respond to potential security incidents
• Review and update your app’s policies and procedures to ensure that they remain current and effective
• Conduct periodic risk assessments to identify new threats and vulnerabilities to PHI
• Conduct regular compliance audits to ensure that your app remains HIPAA-compliant

How much does a HIPAA compliance application development cost?

The cost of developing a HIPAA-compliant application will depend on various factors, including the complexity of the application and its features, the number of users it needs to accommodate, and the type of technology used. Generally speaking, you can expect to pay anywhere from $50,000 – $250,000 for custom development. This cost can also vary depending on whether you’re using an off-the-shelf solution or building your HIPAA-compliant solution from scratch.

Discuss your requirements with us to find out how much it would cost to build a HIPAA-compliant health tech application with Gaper.

What factors could affect the development costs of a HIPAA-compliant solution?

Several factors can affect the development costs of a HIPAA-compliant solution:

• Scale and complexity: The cost of developing a HIPAA-compliant application will depend on the size and complexity of the project. A small-scale application with basic features may be less expensive than a large-scale one with multiple advanced features.
• The number of features: Adding features such as encryption, authentication, user access control and other security measures will increase the overall development cost. It is important to consider which features are necessary for the application to estimate the development costs accurately.
• Maintenance and support costs: Ongoing maintenance and support will add up over time, so it is important to factor this into the budget when determining how much to spend on developing a HIPAA-compliant solution.
• Availability of resources: Certain skills and resources may be more difficult or costly depending on their availability within your local area or online marketplaces. This could affect the overall cost of developing a HIPAA-compliant solution.

Conclusion

Designing HIPAA-compliant and secure health tech apps for iOS is essential for protecting patients’ sensitive health information and avoiding potentially severe legal and financial penalties. By understanding the basics of HIPAA compliance, conducting a comprehensive risk analysis, implementing key technical safeguards, and training your employees on HIPAA regulations, you can ensure that your app is designed to protect PHI and complies with all relevant regulations.

While developing a HIPAA-compliant health tech app may require significant time and resources, ensuring patient privacy and avoiding non-compliance penalties make it well worth the effort.

FAQs

• What is a HIPAA-compliant application?

A HIPAA-compliant application is an app that meets all the requirements of the US Department of Health and Human Services (HHS) for protecting patients’ personally identifiable information (PII). It must also have the necessary security measures to ensure personal health data’s confidentiality, integrity, and availability.

• How can I make sure my application is HIPAA compliant? 

To comply with HIPAA guidelines, your app should include features such as authentication, user access control, and encryption. Additionally, you should establish policies for handling patient data and perform regular security audits to ensure compliance with these policies.

• Is there any software available to help me build a HIPAA-compliant application? 

Yes, there are several tools available that can help you build a secure and HIPAA-compliant app. These tools provide features such as user authentication, encryption, and access control. They also come with pre-built templates to quickly set up common features like login pages or database connections.

• Why do I need to use a HIPAA Compliant Application? 

Using a HIPAA Compliant Application ensures that the data stored and transmitted through the application is secure and private. This is especially important for healthcare providers, who must maintain sensitive patient information following HIPAA guidelines.

• How much does it cost to develop a HIPAA Compliant Application? 

The cost of developing a HIPAA-compliant application will depend on the complexity of the project and the number of features required. Businesses should expect to pay anywhere from $30,000 to $150,000 for basic applications, although costs can increase significantly with more complex features such as encryption or authentication.

• How often do I need to update my HIPAA Compliant Application? 

It is recommended that businesses update their HIPAA-compliant applications regularly to ensure they meet all current privacy and security guidelines. Additionally, companies may be required to update their applications to maintain compliance or address new regulations or technological changes.